R&D ARTICLES

• Involve Patients In Product Development … From The Beginning

  When bringing new therapies to market, it’s no longer just about efficacy and safety data when trying to gain regulatory approval. Nowadays, input from patients throughout the development of medical products is more important than ever.

• How Small Biotechs Can Implement Pharmacovigilance Systems

  Learnings on how to implement drug safety protocols effectively — both time-wise and cost-wise

• Inside The Planning Of Audentes' Future Manufacturing Facility

  A Q&A regarding Audentes Therapeutics’ Sanford, NC future facility, which will manufacture the company’s portfolio of adeno-associated virus (AAV)-based gene therapies aimed at targeting serious rare neuromuscular diseases.

• Small Pharma-Service Entrepreneurs Make A Big Impact

  Over the past year, I have spoken with dozens of rising entrepreneurs – those people who are building the next wave of innovative, technology-focused pharma services companies. These are the unsung heroes of drug development.

• Tips For Biotechs Considering Building Their Own Facilities

  The engineering discipline and technical skills needed to build a new biopharma facility are generally absent within a startup biotech. Here are some key issues to consider when tackling this daunting challenge.

• It’s Time To Recalibrate The Pharma Supply Chain

  After the COVID crisis, pharma supply chains need to be recalibrated. So, what needs to be done with parties upstream (suppliers) and those that are downstream (customers) before it is too late?

• Leading With Data And Digital In The Life Sciences

  In this first article of our series on data sciences and AI, we define common discipline and technology terms and talk about what kind of leadership is necessary.

• Why COGs Will Demand More Attention From Biosimilar Makers

  Without continued innovation in the manufacturing and analytical components of biosimilar development, the biosimilar value proposition becomes less feasible for pharma manufacturers.

• Why Is Antibiotic Development In The U.S. Disappearing?

  Today, 95 percent of antibiotics in development are being studied by smaller biotechs, including Paratek Pharmaceuticals. Today, the company is on a strong trajectory, but its ups and downs show why antibiotic companies fail and few new antibiotics reach patients.

• The Viral Startup

  ViralClear, formed in March 2020 to obtain a drug whose potential use against COVID-19 already has substantial support in evidence. The company is employing considerable industry expertise to move it into clinical development.